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Clinical Trials/NCT03190395
NCT03190395
Unknown
Not Applicable

Compared With 2 Different Ablation Strategies Clinical Outcome for Treating Patients With Paroxysmal Atrial Fibrillation,Prospective Randomised Study

Zhujiang Hospital1 site in 1 country120 target enrollmentJanuary 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paroxysmal Atrial Fibrillation
Sponsor
Zhujiang Hospital
Enrollment
120
Locations
1
Primary Endpoint
Maintenance time of sinus rhythm
Last Updated
7 years ago

Overview

Brief Summary

Atrial fibrillation (AF) is the most serious atrial electrical activity disorders, is also one of the common tachyarrhythmias.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Detailed Description

Atrial fibrillation (AF) refers to the orderly loss of atrial electrical activity, replaced by rapid and disorderly atrial fibrillation wave, is the most acute atrial electrical activity disorders, is also one of the common tachyarrhythmias. So far, the mechanism of atrial fibrillation has not yet been completely clarified. At present, there are various mechanisms to participate in the occurrence and maintenance of atrial fibrillation, which mainly involves two aspects. One is the triggering factor of atrial fibrillation, and the other is the occurrence and maintenance of atrial fibrillation (substrate). Trigger factors are varied, including sympathetic and parasympathetic stimulation, bradycardia, atrial premature beats or tachycardia, atrioventricular bypass and acute atrial pull, etc, which pulmonary vein electrical activity triggered the most common, but also is an most important theoretical Basis for the Radiofrequency Catheter Ablation of Atrial Fibrillation . Substrate is a necessary condition for the onset and maintenance of atrial fibrillation. Electrical remodeling and structural remodeling are by shortening the atrial effective refractory period. Atrial dilatation and atrial fibrosis play a major role in the formation of atrial fibrillation reentry.Circumferential pulmonary Vein Isolation (CPVI) is considered to be the cornerstone of paroxysmal atrial fibrillation ablation, but recently reported in the literature that pure CPVI treatment for paroxysmal atrial fibrillation the 5-year success rate as low as 46.6%, and the incidence of atrial reentry tachycardia is also high in the follow-up period. Therefore it is necessary for us to explore whether the success rate of CPVI combined with Leftatrium Roofline Ablation (CPVI + LARA) for paroxysmal atrial fibrillation is higher than the pure CPVI.

Registry
clinicaltrials.gov
Start Date
January 20, 2019
End Date
August 31, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zhujiang Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (1)Patients between 18-80 year-old with paroxysmal atrial fibrillation have radio frequency ablation operation indication and are willing to require AF ablation therapy.
  • (2)Voluntary consent of informed consent (3)No AF Ablation history before admission

Exclusion Criteria

  • (1) Permanent or persistent AF (2) The diameter of left atrium \>50mm (3) Previous AF/AFL/AT Radio Frequency Ablation (4) Congenital heart disease and/or Cardiac Surgical procedures (5) AF with rheumatic valvular disease (6) LV ejection fraction \<45% (7) Intracardiac thrombi

Outcomes

Primary Outcomes

Maintenance time of sinus rhythm

Time Frame: The two groups will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation

To evaluate the effectiveness of the ablation operation, we will observe how long will these patients keep sinus rhythm after operation.

Secondary Outcomes

  • The Left Ventricular Ejection Fraction(Patients's LV ejection fraction will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation)
  • The size of the left atrium(Patients's size of the left atrium will be assessed from 3 months later operation until the recurrence of atrial fibrillation or up to 36 months after operation)

Study Sites (1)

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